Country Approval Specialist - Buenos Aires, Argentina - Thermo Fisher Scientific

Thermo Fisher Scientific

Empresa verificada

Buenos Aires, Argentina

hace 1 semana

Publicado por:

Sofía Rodríguez

beBee Recruiter

Descripción

CAS:
As PPD CAS, the following will be the responsabilities:

Prepares, reviews and coordinates, under guidance, local regulatory submissions

therapy approvals, viral safety dossiers, import license) in alignment with global

submission strategy.

Provides, under guidance local regulatory strategy advice (MoH &/or EC) to

internal clients.

Provides project specific local SIA services and coordination of these projects.
May have contact with investigators for submission related activities.
Keycontact at country level for either Ethical or Regulatory submissionrelated

activities.

Coordinates, under guidance, with internal functional departments to ensure

various site start-up activities are aligned with submissions activities and

mutually agreed upon timelines; ensures alignment of submission process for

sites and study are aligned to the critical path for site activation.

Achieves PPD's target cycle times for site.
May work with the startup CRA(s) to prepare the regulatory compliance review

packages, as applicable.

May develop country specific Patient Information Sheet/Informed Consent form

documents.

May assist with grant budgets(s) and payment schedules negotiations with sites.
Supports the coordination of feasibility activities, as required, in accordance with

agreed timelines.